DiscoveryInvestigate whether a feature introduces a new regulated activity
Investigate whether a capability introduces a new product category, regulated activity, or duty. Consider the intended use and real user experience before translating the answer into a requirement.
AudienceConsider how the people using the product affect its duties
Research questions involving children, patients, consumers, employees, or professional users. Explore how the target audience changes expectations for safety, information, accessibility, or data handling.
PositioningExamine the regulatory implications of a proposed product claim
Examine what an intended claim implies about the product and the evidence behind it. Prepare a joint discussion with marketing, technical, and regulatory colleagues before launch messaging is finalized.
ExpansionRevisit the requirements before taking a product to another market
Research the proposed destination and compare it with the product’s existing market assumptions. Outline differences in labeling, roles, permissions, or supporting documentation for further assessment.
PrioritizationMake obligations and unresolved questions part of prioritization
Draft a view of regulatory dependencies, evidence needs, and unresolved decisions. Use that research to inform sequencing and ownership alongside customer value, cost, and technical feasibility.
LifecycleAccount for the duties that continue after a product release
Explore how updates, complaints, repairs, recalls, or end-of-life arrangements affect the product. Identify the operational questions that should be addressed before the roadmap moves on.